ES2587729T3 - Pressure compensating device and receptacle - Google Patents

Pressure compensating device and receptacle Download PDF

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Publication number
ES2587729T3
ES2587729T3 ES13708640.1T ES13708640T ES2587729T3 ES 2587729 T3 ES2587729 T3 ES 2587729T3 ES 13708640 T ES13708640 T ES 13708640T ES 2587729 T3 ES2587729 T3 ES 2587729T3
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ES
Spain
Prior art keywords
pressure compensating
compensating device
receptacle
container
fluid
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
ES13708640.1T
Other languages
Spanish (es)
Inventor
Alexander CEDERSCHIÖLD
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Becton Dickinson and Co Ltd
Original Assignee
Becton Dickinson and Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority to US201261605433P priority Critical
Priority to US201261605433P priority
Application filed by Becton Dickinson and Co Ltd filed Critical Becton Dickinson and Co Ltd
Priority to PCT/US2013/028617 priority patent/WO2013130971A1/en
Application granted granted Critical
Publication of ES2587729T3 publication Critical patent/ES2587729T3/en
Application status is Active legal-status Critical
Anticipated expiration legal-status Critical

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Classifications

    • FMECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F16ENGINEERING ELEMENTS AND UNITS; GENERAL MEASURES FOR PRODUCING AND MAINTAINING EFFECTIVE FUNCTIONING OF MACHINES OR INSTALLATIONS; THERMAL INSULATION IN GENERAL
    • F16KVALVES; TAPS; COCKS; ACTUATING-FLOATS; DEVICES FOR VENTING OR AERATING
    • F16K17/00Safety valves; Equalising valves, e.g. pressure relief valves
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/14Details, e.g. provisions for hanging or shape retaining means; Accessories therefor, e.g. inlet or outlet ports, filters or caps
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/14Details, e.g. provisions for hanging or shape retaining means; Accessories therefor, e.g. inlet or outlet ports, filters or caps
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2096Combination of a vial and a syringe for transferring or mixing their contents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/14Details, e.g. provisions for hanging or shape retaining means; Accessories therefor, e.g. inlet or outlet ports, filters or caps
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006Piercing means
    • A61J1/201Piercing means having one piercing end
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/14Details, e.g. provisions for hanging or shape retaining means; Accessories therefor, e.g. inlet or outlet ports, filters or caps
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2048Connecting means
    • A61J1/2055Connecting means having gripping means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/14Details, e.g. provisions for hanging or shape retaining means; Accessories therefor, e.g. inlet or outlet ports, filters or caps
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2068Venting means
    • A61J1/2072Venting means for internal venting
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T137/00Fluid handling
    • Y10T137/7722Line condition change responsive valves
    • Y10T137/7781With separate connected fluid reactor surface
    • Y10T137/7784Responsive to change in rate of fluid flow

Abstract

Pressure compensating device (10) comprising: a container (12) for attachment to a receptacle (22), to allow pressure compensation between the container (12) and the receptacle (22), the container (22) comprising a first camera (16) and a second camera (14); and a ventilation channel (28) extending between the first chamber (16) and a distal opening of the ventilation channel (28), wherein when the receptacle (22) is connected to the pressure compensating device (10), the ventilation channel (28) establishes direct fluid communication between the first chamber (16) and the receptacle (22), and in which a longitudinal axis of the pressure compensating device (10) is configured to align with or parallel to a longitudinal axis of the receptacle (22) when the pressure compensating device (10) is coupled to the receptacle (22), in which the container (12) comprises a movable wall (36) disposed between the first chamber (16) and the second chamber (14), and in which the mobile wall (36) slides from a first position in which the mobile wall (36) is adjacent to a proximal end of the ventilation channel (28), to a second position in which the movable wall (36) is adjacent to the former distal stretch of the ventilation channel (28), characterized in that the ventilation channel (28) is defined by a fluid transfer element (24), the fluid transfer element (24) defines an access channel (30) of fluid extending between an access hole (32) located at a proximal end of the fluid transfer element (24) and a distal tip (26), and because the second chamber (14) is disposed between the wall (36) mobile and a distal end of the ventilation channel (28).

Description

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DESCRIPTION

Pressure compensating device and receptacle Background of the invention Field of the invention

This invention generally relates to devices for the reconstitution of a first fluid with a second fluid and more particularly a pressure compensating device for the union between a fluid container and a receptacle for compensating the pressure inside the container and the receptacle.

Background of the related technique

Certain drugs or medications (these terms being used interchangeably herein) are preferably provided in powder or dry form (such as a lyophilized form), and require reconstitution prior to administration. Lyophilized drugs, for example, are normally supplied in a freeze-dried form that needs to be mixed with a diluent to reconstitute the substance in a form that is suitable for injection. Medications can also be provided in other dry forms or powder that require reconstitution.

In addition, drugs can be provided as multi-part systems that need to be mixed prior to administration. For example, one or more liquids (for example, fluid components (in suspension or liquids)), and / or dry components (for example, powdered or granular) may be provided in a drug container or in a delivery device that require be mixed prior to administration. Gonadatropin and interferon are examples of such multi-component substances that are normally mixed just before being administered to a patient.

The reconstitution of drugs generally involves the transfer of a solvent from a container to a sealed vial containing the drug in powder or liquid form, by means of a needle, a syringe or a transfer system. In some circumstances, the reconstituted fluid may be released unintentionally into the atmosphere in a gaseous form or by aerosolization, during the extraction of the needle from the vial and while the needle is inside the vial if there is a pressure difference between the inside of the vial and the surrounding atmosphere.

Certain drugs, medications and drug systems can become toxic when they are reconstituted, creating a risk of contamination for physicians, pharmaceutical personnel and patients. When such toxic substances are prepared and administered, care must be taken to avoid contamination. Safety cabinets, cabinets or insulators are often used to prepare drugs to reduce the risk of toxic substances leaking into the surrounding environment. However, such facilities are not portable and generally require considerable space in a weather environment. Such facilities are also expensive to install, maintain and repair.

Alternatively, a closed pressure compensating device may be attached between the vial and fluid container during reconstitution to reduce the risk of the reconstituted fluid being released involuntarily. The pressure compensating device comprises a gas container in communication with the inside of the vial, which ensures that neither an increase in pressure nor a vacuum can occur inside the vial when gas or liquid is injected into or removed from the vial. The gas container can be filled with clean or sterilized air before use to ensure that the contents of the vial are not contaminated with airborne particles such as dust, pollen, mold or bacteria and other undesirable substances. A closed pressure compensator system for use in drug reconstitution is described in US Patent No. 8,029,747, entitled "Pressure Compensation Device, Receptacle and Method".

An additional pressure compensating device is described in US Patent No. 7,900,659, entitled "Pressure compensating device for vial access" (hereinafter "the '659 patent"). The '659 patent discloses a vial access device that has a pressure compensating chamber delimited by a movable disk. The disc moves automatically inside the chamber to keep the vial at atmospheric pressure during reconstitution and aspiration of the contents of the vial. The device also includes a hydrophobic filter disposed in a hole between the vial and the pressure compensating device to prevent fluid from entering the pressure compensating chamber.

A disadvantage with such pressure compensation device for vial access is that the filter can be clogged with solid particles such as dust, transported agglomerates or high viscosity fluids of the fluid transferred between the pressure compensation device for vial access and the vial . Solid particles can hinder or prevent pressure compensation. The pressure compensation device for road access occupies a valuable space around the opening of the vial since the longitudinal axis of the pressure compensating chamber is arranged at an angle of 90 degrees with respect to the longitudinal axis of the vial. Therefore, it may be difficult to use the pressure compensating device in locations that have limited space such as hospital rooms, laboratories and other weather environments.

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In addition, a vial having such pressure compensation device for access to a connected vial is generally heavy on the top and can fall if the pressure compensation device for vial access is not held by a user. The pressure compensating device of the present invention is intended to solve the deficiencies identified above.

Document US 2011/0168294 A1 refers to a tank filling device having a ventilation unit that provides gas access to a cartridge during emptying of the cartridge with part of the ventilation unit attached to a rotating part.

WO 2011/150037 A1 discloses a device that has two annular compartments separated by a bladder with the first compartment in fluid communication with a receptacle by means of a conduit. The longitudinal axis of the pressure compensating device disclosed is aligned with the longitudinal axis of the receptacle.

EP 2 036 529 A1 discloses a device comprising a camera that has two compartments separated by a sliding wall. The first compartment is in fluid communication with the receptacle by means of a second communication channel. The camera extends perpendicularly outward from the portion of the device that joins the receptacle.

Document FR 2 951 638 A1 discloses an air tank that has two interior compartments. The first inner compartment is in fluid communication with the receptacle through a check valve. The air reservoir extends perpendicularly outward from the part of the device that joins the receptacle.

Document US 7 / 900,659 B2 discloses a camera that has two compartments separated by a sliding disk. The first compartment is in fluid communication with the receptacle through a ventilation hole. The camera extends perpendicularly outward from the part of the device that joins the receptacle.

US 4,564,054 A describes a device to prevent air pollution when a substance is transferred from a container to a second container.

Summary of the invention

According to an embodiment of the invention, a pressure compensating device includes a container for attachment to a receptacle, to allow for pressure compensation between the container and the receptacle. The container includes a first chamber and a second chamber. The device also includes a fluid transfer element that defines a ventilation channel that extends between the first chamber and a distal end of the needle. According to the invention, when the receptacle is connected to the pressure compensating device, the ventilation channel establishes direct fluid communication between the first chamber and the receptacle. Additionally, a longitudinal axis (A) of the pressure compensating device is configured to be aligned with or parallel to a longitudinal axis (B) of the receptacle when the pressure compensating device is attached to the receptacle.

The second chamber is arranged between the movable wall and a distal end of the ventilation channel. The mobile wall slides from a first position in which the mobile wall is adjacent to a proximal end of the ventilation channel, to a second position in which the mobile wall is adjacent to the distal end of the ventilation channel. In addition, the ventilation channel is defined by a fluid transfer element through which the fluid transfer element defines a fluid access channel that extends between an access hole located at a proximal end of the fluid transfer element. and a distal tip.

These and other aspects and features of the present invention, as well as the methods of operation and the functions of the related elements of structures and the combination of parts and manufacturing savings, will be more evident with the consideration of the following description and the appended claims. with reference to the attached drawings, all forming a part of this description, in which the reference numbers designate the corresponding parts in the different figures. However, it should be expressly understood that the drawings are only intended to illustrate and describe and are not intended to be a definition of the limits of the invention. As used in the description and in the claims, the singular form of "a", "a", and "the" includes references to the plural unless the context clearly indicates otherwise.

Brief description of the drawings

In order to facilitate the understanding of the invention, the accompanying drawings and the description illustrate preferred embodiments thereof, from which the invention can be understood and appreciated, different embodiments of its structures, construction and method of operation and A lot of advantages.

Figure 1 is a perspective view of a pressure compensating device with receptacle and receptacle connector depicted in phantom lines, according to an embodiment of the present invention.

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Figure 2 is a cross-sectional view of the pressure compensating device of Figure 1, according to an embodiment of the present invention.

Figure 3 is a perspective view of a container of the pressure compensating device of Figure 1, according to an embodiment of the present invention.

Figure 4 is a perspective view of a movable wall of the pressure compensating device of Figure 1, according to an embodiment of the present invention.

Figure 5 is an exploded perspective view of the needle and the pierceable membrane of the pressure compensating device of Figure 1, according to an embodiment of the present invention.

Figure 6 is a perspective view of the receptacle connector of the pressure compensating device of Figure 1, according to an embodiment of the present invention.

Figure 7 is a perspective view of an assembly for the reconstitution of a medicament or drug, according to an embodiment of the present invention.

Figure 8 is a cross-sectional view of a pressure compensating device according to a further embodiment of the present invention.

Figure 9 is a cross-sectional view of a pressure compensating device according to a further embodiment of the present invention.

Figure 10A is a schematic representation of a pressure compensating device according to a further embodiment of the present invention.

Figure 10B is a schematic representation of the pressure compensating device of Figure 10A, folded approximately 90 °, according to an embodiment of the present invention.

Detailed description of the invention

As used herein, spatial or directional terms such as "above", "below", "above", "below", "the top", "the bottom" and the like refer to the invention as shown in the figures. However, it should be understood that the invention can assume different alternative orientations and, therefore, such terms will not be considered as limiting.

The terms "clean" and "aseptic" fluid refer to fluids that have been filtered through a filter to remove particles and / or variable microorganisms to such an extent that the fluid is classified as aseptic as defined by the competent authorities and / or by the generally applicable standards. The degree of purity can be expressed in terms of the largest particles that can pass through the filter for a given fluid flow rate. In some cases, a clean fluid of this type will not have any particles or only a few particles that exceed 5 pm. However, the allowed particle size is determined by the requirements of the present application. For other drug treatments, substantially all particles that have a size that exceeds 0.15 pm are removed from the fluid by the air particle filter.

The term "sterilized" and / or "sterile" refers to fluids that have undergone a sterilization method to eliminate viable microorganisms using methods approved by the competent regulatory authorities. For example, the current European regulations for sterilization of medical devices are evaluated according to the EN 556-1 standard. Other regulations may exist in other countries. Exemplary sterilization methods include ethylene oxide sterilization, irradiation sterilization, heat sterilization and / or water vapor, as well as other accepted methods known in the art. The requirements of European standards require that the theoretical probability that a viable microorganism is present in / within the sterilized device is equal to or less than 1x10 "6.

The terms "flexible material", "expandable material" and "compressible material", as used herein, are defined as any material that is capable of being folded, expanded or compressed with an increase / reduction in volume in the container of fluid respectively. "Flexible material" is intended to mean material that can be easily folded or twisted or folded by hand or material that can be repeatedly folded and / or folded without breakage or the development of visible defects.

The terms "rigid" and "non-compressible material", as used herein, are intended to mean material that is unable to be folded, expanded or compressed with an increase / decrease in volume in the fluid container respectively. Non-nested plastics can be defined as plastic that has a modulus of elasticity in flexion, or if this is not applicable, then in tension, that is not greater than 70 MPa under conditions, such as relative temperature and humidity conditions, specified in the international standard ISO 291.

"Plugs" or closures for receptacles are defined by international standards such as ISO 8362-5 and ISO

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8536-2: 2010.

An embodiment of the present invention is directed to devices and assemblies for pressure compensation for use with devices and systems for reconstitution of drugs. More specifically, the realization of the present invention provides a pressure compensating device that can be used during the reconstitution of a toxic substance to create a closed system, to reduce the possibility that patients, clinical staff, doctors and other medical personnel are exposed to Toxic substance

Additionally, the pressure compensating device, according to one embodiment, is configured to have a reduced total volume compared to previously known devices, to save space in and around the top of a medical receptacle. A pressure compensating device configured with a reduced total volume is easier to attach to a medical receptacle. Also, because the pressure compensating device is generally smaller than the known pressure compensating devices, it is easier for a user to read the labels of the receptacle and / or the injector marks, and see the contents of the receptacle, of the injector and / or the pressure compensating device during use. In addition, certain embodiments of the pressure compensating device may be easier to use in a table reconstitution vials mixer (or "reconstitution vials agitator") that mixes the contents of a receptacle connected to it. More particularly, as described herein, the pressure compensating device may include structures and configurations to prevent the receptacle from falling if it is left standing with the pressure compensating device attached to it, and to prevent the device and / or receptacle roll on a flat or inclined surface when the device is left resting on its side.

With reference to Figures 1 to 7, a pressure compensating device 10 according to an embodiment of the present invention is shown. The pressure compensating device 10 includes a container 12 defining an open chamber 14 and a sealed chamber 16. The open chamber 14 and the sealed chamber 16 are not in fluid communication between them. However, a thin coating 18 or film can be applied to an inner wall of the container 12 as a lubricant. The film 18 can be transferred between the respective cameras 14, 16 as long as no other fluid transfer occurs. The open chamber 14 is, optionally, in fluid communication with the ambient air and atmospheric pressure.

The device 10 also includes a connector 20 for attaching the device 10 to a receptacle 22. The receptacle 22 may be any medical container formed of any suitable sterile material, including vials, cartridges, test tubes, sample collection tubes, syringes and Similar. The device 10 is configured to allow pressure compensation between the sealed chamber 16 and the receptacle 22. The receptacle 22 may be a standard medical vial having a volume of 3 ml, 5 ml, 13 ml, 16.7 ml or any Other suitable standard or custom volume. The maximum volume of the container 12 preferably corresponds to the volume of the receptacle 22. However, the container 12 may vary in volume from about 1 cm 3 to about 1 liter, depending on the drug or the substance being reconstituted. The receptacle 22 may contain a solid, liquid or gaseous pharmaceutical, biological or veterinary substance and may be sealed by a lid and / or an elastomer or membrane plug.

The pressure compensating device 10 also includes a connector 21 for attaching the pressure compensating device 10 to a fluid container 110, such as a syringe or injector. The connector 21 can be a Luer-type closure, bayonet, pressure mechanism or other connection capable of establishing a detachable connection between a cylindrical container and a fluid access hole.

The pressure compensating device 10 also includes a fluid transfer element 24, such as a needle, needle cannula, lumen, channel or spur, which has a distal tip 26 and defines a ventilation channel 28. The ventilation channel 28 has a distal opening adjacent to the distal tip 26 for insertion into the receptacle 22. The ventilation channel 28 extends between the receptacle 22 and the sealed chamber 16. The transfer element 24 further includes a fluid access channel 30 extending between an access hole 32, at a proximal end of the fluid transfer element 24, and the distal tip 26.

The pressure compensating device 10 also includes a pierceable membrane 34 inserted in or connected to the access hole 32. The membrane 34 is configured to be resealable through a needle or splint, thereby establishing fluid communication between the needle or spur and the access channel 30 through the membrane 34. In a non-limiting embodiment of the invention , the pressure compensating device 10 also includes a second membrane (not shown) located at the distal end of the fluid transfer element 24 that is arranged to be pressed against the cover or sealing means of a receptacle 22.

As shown in Figure 7, the pressure compensating device 10 has a longitudinal axis A. When the compensating device 10 joins the receptacle 22, the longitudinal axis A is arranged in alignment and / or parallel with a longitudinal axis B of the receptacle 22. In addition, the fluid transfer element 24 and ventilation channel 28 are disposed along the longitudinal axis A of the pressure compensating device 10.

When the fluid is injected into the receptacle 22 or removed from it, the ventilation channel 28 of the device 10

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Pressure compensator allows gas to flow from inside the receptacle 22 to the sealed chamber 16 or from the sealed chamber 16 to the receptacle 22, thereby compensating for the pressure inside the receptacle 22 and in the sealed chamber 16. The fluid cannot leave the sealed chamber 16, which eliminates, or at least reduces, the risk that any substance that is inside the receptacle 22 is released into the atmosphere in gaseous form or by aerosolization during insertion or extraction of the fluid transfer element 24 of the receptacle 22. The use of a pressure compensating device 10 also reduces the risk that the pressure in the receptacle 22 increases. The increase in pressure in the receptacle 22 may cause the receptacle 22 to drip or become deformed, in addition to increasing the risk of contamination of the reconstituted fluid.

With continued reference to FIGS. 1 to 7, the open chamber 14 is delimited by a mobile wall 36 and walls 38 nested from the container 12. The open chamber 14 is located between a lower surface of the mobile wall 36 and the receptacle 22. The Mobile wall 36 can function as a piston that is movable within the container 12 to compensate for the pressure inside the receptacle 22 and the sealed chamber 16. The mobile wall 36 is freely movable because it will automatically pass between a first position, in which the wall 36 is adjacent to the proximal end of the container 12, and a second position in which the wall is adjacent to the distal end of the container 12. The wall 36 is automatically movable, because it passes from one position to another based solely on the extraction or injection of fluids from the receptacle 22. When the fluid enters the receptacle, the mobile wall 36 moves down through the container 12, increasing from this mode the volume of the sealed chamber 16. As the pressure in the receptacle 22 is reduced, the wall moves in the proximal direction, thereby reducing the volume of the sealed chamber 16.

In a non-limiting embodiment, the nipple walls 38 of the fluid container 12 are made of transparent or semi-transparent material so that the mobile wall 36 is visible from the outside of the pressure compensating device 10 and can serve as a visual indicator of how much fluid has been added or removed from a receptacle 22.

The mobile wall 36 may be formed of a nigged or flexible material. For example, the mobile wall 36 may be constructed of one or more materials that are impervious to fluids (i.e., that do not allow the passage of a fluid) such as silicone, a thermoplastic polyester elastomer, (TPE), or rubber. The mobile wall 36 must create a seal between the sealed chamber 16 and the open chamber 14 to prevent the vented gas from escaping through the chamber 14 open to ambient air. The mobile wall 36 may also include a fluid impermeable coating 40 and / or an outer annular seal 42, such as an annular shaped seal to abut the inner wall of the container 12.

In a further non-limiting embodiment, the mobile wall 36 is an annular element defining a central opening 46. The fluid transfer element 24 is inserted through the central opening 46. In this case, the mobile wall 36 may also include an inner annular seal 44 disposed between the central opening 46 and the fluid transfer element 24 creating a seal between them.

In a further non-limiting embodiment, the sealed chamber 16 is at least partially filled with sterilized air, which enters the chamber 16 through a fluid inlet (not shown), such as a valve, in communication with ambient air. A filter may be arranged at the inlet to sterilize the incoming air. The filter can be removable or integral with the inlet. The filter may be any suitable commercially available filter, such as a particulate air filter having a pore size of 0.2 pm or less, a carbon filter, or a hydrophobic filter that allows gas to pass but which prevents the passage of liquids, particles present in the gas, microorganisms and aerosols. As described above, "sterilized air" refers to fluids that have been subjected to a sterilization method to eliminate viable microorganisms using methods approved by the competent regulatory authorities. The open chamber 14 may also be provided with a fluid opening defined by the container 12 to further ensure that the mobile wall 36 is free to move within the container 12.

As shown in Figures 1 and 2, the pressure compensating device 10 has a substantially cylindrical cross section A. Alternatively, at least a part of a pressure compensating device 10 may have a substantially polygonal cross section. Including a polygonal or other non-circular cross section prevents the device 10 and / or the receptacle 22 attached to the wheel on a flat or inclined surface.

Having described an embodiment of a pressure compensating device 10, an assembly 100 for drug reconstitution is now described. With reference to Figure 7 and in a non-limiting embodiment, the assembly includes the pressure compensating device 10, receptacle 22 and fluid container 110. The fluid container 110, such as a syringe, is used to introduce a solvent or drug component into the receptacle 22, through the access channel 30 of the pressure compensating device 10. The fluid container 110 may also include a syringe adapter or injector 111 connected between the syringe 110 and the pressure compensating device 10 as shown in Figure 7. The fluid container 110 must include a needle cannula, access hole without needle, nozzle or other access arrangements for establishing a fluid connection between the fluid container 110 and the access channel 30 of the device 10. The fluid container 110 may be at least partially formed by a thermoplastic material, such as polyethylene or polypropylene, acrylonitrile-butadiene-styrene (ABS), polycarbonate, polyester or any other suitable material. As shown in Figure 7, the longitudinal axis A of the device

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Pressure compensator 10 is aligned with the longitudinal axis B of the receptacle 22 and with the longitudinal axis C of the fluid container 110, thus forming a linear assembly.

In a non-limiting embodiment of the assembly and as shown in Fig. 7, the pressure compensating device 10 may be formed in solidarity with at least one component of the receptacle 22. For example, the pressure compensating device 10 may be formed in solidarity with a cover, neck, seal or perforable partition of receptacle 22.

Referring now to Figures 8 and 9, and in a further non-limiting embodiment of the pressure compensating device 10, the container 12 includes a deformable bellows 52 disposed within the container 12. The bellows 52 is disposed between a sealed chamber 16 and a chamber 14 opened in the same manner in which the mobile wall 36 maintains the separation between the chambers 14, 16 in the previously described embodiments. The bellows 52 is formed of a flexible material such as rubber or plastic that expands or contracts in response to a change in the volume of the sealed chamber 16. An inflatable ball can also be used instead of bellows 52.

With particular reference to Figure 8, the bellows 52 is attached to a distal part of the container 12. In this configuration, when fluid from the receptacle 22 enters the sealed chamber 16 through the ventilation channel 28, the fluid flows around the bellows 52 causing the bellows 52 to contract. When the bellows 52 contracts, the volume of the sealed chamber 16 increases.

Alternatively, and with reference to Figure 9, the bellows 52 is attached to a proximal end of the container 12. In this configuration, the bellows 52 expands as the fluid of the receptacle 22 enters the sealed chamber 16 through the ventilation channel 28. The volume of the sealed chamber 16 expands when the volume of the bellows 52 expands.

With reference to Figures 10A and 10B and according to a further non-limiting embodiment of the invention, the pressure compensating device 10 also includes one or more flexible seals 54 connected to or formed in solidarity with other structural parts of the pressure compensating device 10. For example, flexible seals 54 may be included with the sharp walls 38 of the container and / or the fluid transfer element 24 to allow flexion of the container 12 and the fluid transfer element 24. The flexible joints 54 may be formed of any flexible material, including plastic or rubber, which can be easily bent without breaking, and which maintain a bent orientation until straightened by a user. If the flexible seals 54 are formed jointly with the container 12 or the fluid transfer element 24, then the flexible seals 54 will be formed of the same material as the container 12 and / or the element 24. For example, the seals 54 Flexible can be formed by a thermoplastic material, including polyethylene or polypropylene, acrylonitrile-butadiene-styrene (ABS), polycarbonate, polyester or any other suitable material. During use, a user can hold the device 10 and / or receptacle 22 and bend the flexible joints 54 to change the orientation of the device 10 relative to the longitudinal axis (B) of the receptacle.

It is noted that once the one or more flexible joints 54 are bent, the longitudinal axis A of the pressure compensating device is no longer parallel with the longitudinal axis B of the receptacle 22. As shown in Figure 10A, when the joints 54 flexible are in the straight or not offset orientation, the longitudinal axis A of the device 10 is parallel with the longitudinal axis B of the receptacle 22. However, as shown in Figure 10B, when the flexible joints 54 are in the bent orientation , the A axis and the B axis are not parallel. In a non-limiting embodiment, the flexible joint 54 is configured to bend to approximately 90 degrees, thus allowing at least a part of the pressure compensating device 10 to be tilted 90 degrees or more with respect to the longitudinal axis B of the receptacle 22. Bending at least a part of the pressure compensating device 10, so that the longitudinal axis A is not parallel to the longitudinal axis B of the receptacle 22, the device 10 and the receptacle 22 can be placed on a flat or inclined surface. Specifically, during the bent orientation, the device 10 and the receptacle 22 are less likely to roll along the surface, possibly damaging the device 10 and / or the substances contained therein.

While the specific embodiments of the device, set and method have been described in detail, those skilled in the art will understand that, given the general teachings of the description, various modifications and alternatives to those details can be developed. Accordingly, the particular provisions disclosed are intended to be only illustrative and not limiting the scope of the invention that should be considered with the maximum breadth of the appended claims and any and all equivalents thereof.

Claims (15)

  1. 5
    10
    fifteen
    twenty
    25
    30
    35
    40
    Four. Five
    fifty
    1. - Pressure compensating device (10) comprising:
    a container (12) for joining a receptacle (22), to allow pressure compensation between the container (12) and the receptacle (22), the container (22) comprising a first chamber (16) and a second chamber ( 14); Y
    a ventilation channel (28) extending between the first chamber (16) and a distal opening of the ventilation channel (28),
    wherein when the receptacle (22) is connected to the pressure compensating device (10), the ventilation channel (28) establishes direct fluid communication between the first chamber (16) and the receptacle (22), and
    wherein a longitudinal axis of the pressure compensating device (10) is configured to align with or parallel to a longitudinal axis of the receptacle (22) when the pressure compensating device (10) is coupled to the receptacle (22), in which the container (12) comprises a mobile wall (36) disposed between the first chamber (16) and the second chamber (14), and in which the mobile wall (36) slides from a first position in which the mobile wall (36) is adjacent to a proximal end of the ventilation channel (28), to a second position in which the mobile wall (36) is adjacent to the distal end of the ventilation channel (28),
    characterized because
    the ventilation channel (28) is defined by a fluid transfer element (24), the fluid transfer element (24) defines a fluid access channel (30) extending between an access hole (32) located at a proximal end of the fluid transfer element (24) and a distal tip (26), and because
    The second chamber (14) is arranged between the mobile wall (36) and a distal end of the ventilation channel (28).
  2. 2. - Pressure compensating device according to claim 1, wherein a longitudinal axis of the fluid transfer element (24) is aligned with the longitudinal axis of the pressure compensating device (10).
  3. 3. - Pressure compensating device according to claim 1, wherein the first chamber (16) is sealed with respect to the surrounding atmosphere.
  4. 4. - Pressure compensating device according to any one of the preceding claims, wherein the movable wall (36) comprises an annular gasket (42) arranged circumferentially around the movable wall (36) to establish a sealant coupling between the mobile wall (36) and an inner wall of the container (12).
  5. 5. - Pressure compensating device according to any one of the preceding claims, wherein the mobile wall (36) or the container (12) comprises a lubricating coating to allow the mobile wall (36) to slide from the first position to the second position.
  6. 6. - Pressure compensating device according to claims 3 to 5, wherein the mobile wall (36) defines a central opening (46), and the fluid transfer element (24) extends through opening (46) central so that the mobile wall (36) can slide from the first position to the second position along the fluid transfer element (24).
  7. 7. - Pressure compensating device according to claim 6, wherein the movable wall (36) further comprises an annular gasket (44) arranged around the central opening (46) for sealing the transfer element (24) in a sealed manner. of fluid
  8. 8. - Pressure compensating device according to any of the preceding claims, wherein a cross-sectional view of the container (12) is substantially circular.
  9. 9. - Pressure compensating device according to any of the preceding claims, wherein the container (12) is at least partially filled with a sterilized fluid.
  10. 10. - Pressure compensating device according to any of the preceding claims, wherein the first chamber (16) of the container (12) is filled with filtered ambient air.
  11. 11. - Pressure compensating device according to any of the preceding claims, further comprising a plurality of flexible joints (54), in which flexible joints (54) pass from a first position in which the longitudinal axis of the device (10 ) Pressure compensator is parallel to the longitudinal axis of the receptacle (22), to a second position in which the longitudinal axis of at least one portion of the device (10)
    It is not parallel to the longitudinal axis of the receptacle (22).
  12. 12. - Pressure compensating device according to claim 11, wherein the flexible seals (54) are formed in a manner integral with the container (12) or the fluid transfer element (24).
  13. 13. - Pressure compensating device according to claims 1 to 11, wherein the access hole (32) is configured to be connected to a fluid injector (110).
  14. 14. - Pressure compensating device according to claim 13, further comprising a perforable membrane (34) connected to the access hole (32) of the fluid transfer element (24).
  15. 15. - Pressure compensating device according to claim 13 or claim 14, further comprising a connector (21) for connecting the fluid injector (110) to the pressure compensating device (10) and for establishing
    10 fluid connection between the fluid injector (110) and the receptacle (22) through the access channel (32).
ES13708640.1T 2012-03-01 2013-03-01 Pressure compensating device and receptacle Active ES2587729T3 (en)

Priority Applications (3)

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US201261605433P true 2012-03-01 2012-03-01
US201261605433P 2012-03-01
PCT/US2013/028617 WO2013130971A1 (en) 2012-03-01 2013-03-01 Pressure equalizing device and receptacle

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EP (2) EP3072494B1 (en)
JP (2) JP5969634B2 (en)
CN (2) CN104244905B (en)
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US20180058594A1 (en) 2018-03-01
JP6334615B2 (en) 2018-05-30
CN104244905A (en) 2014-12-24
EP2819633A1 (en) 2015-01-07
JP2016172181A (en) 2016-09-29
CA2865502A1 (en) 2013-09-06
CA2865502C (en) 2016-08-23
US20130228239A1 (en) 2013-09-05
EP3072494B1 (en) 2017-10-18
US9822891B2 (en) 2017-11-21
ES2656119T3 (en) 2018-02-23
JP5969634B2 (en) 2016-08-17
EP2819633B1 (en) 2016-06-29
WO2013130971A1 (en) 2013-09-06
CN104244905B (en) 2019-06-04
JP2015508700A (en) 2015-03-23
EP3072494A1 (en) 2016-09-28
CN110090153A (en) 2019-08-06

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